Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
ADVIA Centaur HCY Diluent - 10mL Bottle Catalog number 09877493 (124533) Recalled by Siemens Healthcare Diagnostics, Inc Due to ADVIA Centaur Homocysteine dilution recovery on the diluent...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Siemens Healthcare Diagnostics, Inc directly.
Affected Products
ADVIA Centaur HCY Diluent - 10mL Bottle Catalog number 09877493 (124533), SMN 10310370, and Ancillary Pack Catalog number 03302138 (124581), SMN 10378677. Used on the ADVIA Centaur, ADVIA Centaur XP and ADVIA Centaur CP platforms. For in vitro diagnostic use in the quantitative determination of total homocysteine (HCY) in serum or plasma.
Quantity: 51 units
Why Was This Recalled?
ADVIA Centaur Homocysteine dilution recovery on the diluent identified the percent recovery for the 1:10 patient sample dilutions lower than reported in the Instructions for Use (IFU).
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Siemens Healthcare Diagnostics, Inc
Siemens Healthcare Diagnostics, Inc has 118 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report